Active Ingredient: Setmelanotide
Setmelanotide is indicated for the treatment of obesity and the control of hunger associated with loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, in adults and children 2 years of age and above.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 1 milligrams setmelanotide, once daily at morning, over the duration of 2 weeks. Afterwards, subcutaneous, 2 milligrams setmelanotide, once daily at morning. The maximum allowed total dose is 3 milligrams setmelanotide daily.
For adults and children 12 to 17 years of age, the starting dose is a 1 mg once daily subcutaneous injection for 2 weeks. After 2 weeks, if setmelanotide is well-tolerated, the dose can be increased to a 2 mg once daily subcutaneous injection. If dose escalation is not tolerated, patients may maintain administration of the 1 mg once daily dose.
If additional weight loss is desired in adult patients, the dose can be increased to a 2.5 mg once daily subcutaneous injection. If the 2.5 mg once daily dose is well-tolerated, the dose can be increased to 3 mg once daily.
In patients aged 12 to 17 years, if weight remains above the 90th percentile with the 2 mg once daily subcutaneous injection and additional weight loss is desired, the dose may be increased to 2.5 mg with a maximum dose of 3 mg once daily.
Dose titration in adults and paediatric patients 12 years of age or more:
| Week | Daily dose |
|---|---|
| Weeks 1-2 | 1 mg once daily |
| Week 3 and onward | 2 mg once daily |
| If clinical response is insufficient and 2 mg dose once daily is well tolerated | 2.5 mg once daily |
| If clinical response is insufficient and 2.5 mg dose once daily is well tolerated | 3 mg once daily |
If a dose is missed, the once daily regimen should be resumed at the dose prescribed with the next scheduled dose.
Although no apparent age-related differences have been observed, data obtained from elderly patients is not sufficient to determine whether they respond differently from younger patients. There is no evidence indicating any special precautions are required for treating an elderly population.
Setmelanotide should be injected once daily, at the beginning of the day (to maximise hunger reduction during awake period), without regard to the timing of meals.
Setmelanotide should be injected subcutaneously in the abdomen, alternating the abdominal area each day.
For:
Regimen A: In case that patient age in years is ≥ 6, subcutaneous, 0.5 milligrams setmelanotide, once daily at morning, over the duration of 2 weeks. Afterwards, in case that patient age in years is ≥ 6, subcutaneous, 1 milligrams setmelanotide, once daily at morning, over the duration of 2 weeks. Afterwards, in case that patient age in years is ≥ 6, subcutaneous, 2 milligrams setmelanotide, once daily at morning, over the duration of 2 weeks. Afterwards, in case that patient age in years is ≥ 6 and there is poor response to treatment, subcutaneous, 2.5 milligrams setmelanotide, once daily at morning. The maximum allowed total dose is 2.5 milligrams setmelanotide daily.
Regimen B: In case that patient age in years is ≥ 2 and patient age in years is < 6 and patient weight is < 20 kg, subcutaneous, 0.5 milligrams setmelanotide, once daily at morning.
Regimen C: In case that patient age in years is ≥ 2 and patient age in years is < 6 and patient weight is ≥ 20 kg and patient weight is < 30 kg, subcutaneous, 0.5 milligrams setmelanotide, once daily at morning, over the duration of 2 weeks. Afterwards, in case that patient age in years is ≥ 2 and patient age in years is < 6 and patient weight is ≥ 20 kg and patient weight is < 30 kg, subcutaneous, 1 milligrams setmelanotide, once daily at morning.
Regimen D: In case that patient age in years is ≥ 2 and patient age in years is < 6 and patient weight is ≥ 30 kg and patient weight is < 40 kg, subcutaneous, 0.5 milligrams setmelanotide, once daily at morning, over the duration of 2 weeks. Afterwards, in case that patient age in years is ≥ 2 and patient age in years is < 6 and patient weight is ≥ 30 kg and patient weight is < 40 kg, subcutaneous, 1 milligrams setmelanotide, once daily at morning, over the duration of 2 weeks. Afterwards, in case that patient age in years is ≥ 2 and patient age in years is < 6 and patient weight is ≥ 30 kg and patient weight is < 40 kg, subcutaneous, 1.5 milligrams setmelanotide, once daily at morning.
Regimen E: In case that patient age in years is ≥ 2 and patient age in years is < 6 and patient weight is ≥ 40 kg, subcutaneous, 0.5 milligrams setmelanotide, once daily at morning, over the duration of 2 weeks. Afterwards, in case that patient age in years is ≥ 2 and patient age in years is < 6 and patient weight is ≥ 40 kg, subcutaneous, 1 milligrams setmelanotide, once daily at morning, over the duration of 2 weeks. Afterwards, in case that patient age in years is ≥ 2 and patient age in years is < 6 and patient weight is ≥ 40 kg, subcutaneous, 1.5 milligrams setmelanotide, once daily at morning, over the duration of 2 weeks. Afterwards, in case that patient age in years is ≥ 2 and patient age in years is < 6 and patient weight is ≥ 40 kg, subcutaneous, 2 milligrams setmelanotide, once daily at morning, over the duration of 2 weeks. Afterwards, in case that patient age in years is ≥ 2 and patient age in years is < 6 and patient weight is ≥ 40 kg, subcutaneous, 2.5 milligrams setmelanotide, once daily at morning.
For patients aged 6 to <12 years, the starting dose is a 0.5 mg once daily subcutaneous injection for 2 weeks. If tolerated after 2 weeks, the dose can be increased to 1 mg once daily. If dose escalation is not tolerated, paediatric patients may maintain administration of the 0.5 mg once daily dose. If the 1 mg dose is tolerated after 2 weeks, the dose can be increased to 2 mg once daily. If weight remains above the 90th percentile with the 2 mg once daily subcutaneous injection and additional weight loss is desired, the dose may be increased to 2.5 mg once daily.
Table 1. Dose titration for paediatric patients from 6 to <12 years of age:
| Week | Daily dose |
|---|---|
| Weeks 1-2 | 0.5 mg once daily |
| Weeks 3-5 | 1 mg once daily |
| Week 6 and onward | 2 mg once daily |
| If clinical response is insufficient and 2 mg dose once daily is well tolerated | 2.5 mg once daily |
For patients aged 2 to <6 years, the dose titration in Table 2 should be followed.
For patients aged 2 to <6 years, the starting dose is a 0.5 mg once daily subcutaneous injection for 2 weeks. If the 0.5 mg starting dose is not tolerated, reduce to 0.25 mg once daily. If the 0.25 mg once daily dose is tolerated, continue dose titration.
Table 2. Dose titration for paediatric patients from 2 to <6 years of age:
| Patient weight/treatment week | Daily dose |
|---|---|
| <20 kg | |
| Week 1 and onward | 0.5 mg once daily |
| 20-<30 kg | |
| Weeks 1-2 | 0.5 mg once daily |
| Week 3 and onward (if clinical response is insufficient and 0.5 mg dose is well tolerated) | 1 mg once daily |
| 30-<40 kg | |
| Weeks 1-2 | 0.5 mg once daily |
| Weeks 3-4 (if clinical response is insufficient and 0.5 mg dose once daily is well tolerated) | 1 mg once daily |
| Week 5 and onward (if clinical response is insufficient and 1 mg dose once daily is well tolerated) | 1.5 mg once daily |
| ≥40 kg | |
| Weeks 1-2 | 0.5 mg once daily |
| Weeks 3-4 (if clinical response is insufficient and 0.5 mg dose once daily is well tolerated) | 1 mg once daily |
| Weeks 5-6 (if clinical response is insufficient and 1 mg dose once daily is well tolerated) | 1.5 mg once daily |
| Weeks 7-8 (if clinical response is insufficient and 1.5 mg dose once daily is well tolerated) | 2 mg once daily |
| Week 9 and onward (if clinical response is insufficient and 2 mg dose once daily is well tolerated) | 2.5 mg once daily |
The prescribing physician should periodically assess response to setmelanotide therapy. In growing children, the impact of weight loss on growth and maturation should be evaluated.
Weight loss and control of hunger associated with setmelanotide can be maintained as long as the therapy is continued uninterrupted. If treatment is discontinued, or if compliance to the dosing regimen is not maintained, symptoms of POMC deficiency obesity will return.
If a dose is missed, the once daily regimen should be resumed at the dose prescribed with the next scheduled dose.
Setmelanotide should be injected once daily, at the beginning of the day (to maximise hunger reduction during awake period), without regard to the timing of meals.
Setmelanotide should be injected subcutaneously in the abdomen, alternating the abdominal area each day.
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